Key result
This protocol outlines a prospective study to evaluate CytoSorb hemoadsorption for clearing ticagrelor and rivaroxaban before urgent orthopedic surgery; no results are available yet.
Why the study?
Major orthopedic trauma in patients on ticagrelor or rivaroxaban poses bleeding risks and reversal challenges, and the potential use of CytoSorb for drug removal in trauma surgery remains unexplored.
Does CytoSorb hemoadsorption improve the pharmacokinetic profile of drug clearance in trauma patients receiving ticagrelor or rivaroxaban requiring urgent orthopedic surgery?
Does CytoSorb hemoadsorption improve the pharmacokinetic profile of drug clearance in trauma patients receiving ticagrelor or rivaroxaban requiring urgent orthopedic surgery?
This protocol outlines a prospective study to evaluate the feasibility and safety of CytoSorb hemoadsorption for rapid removal of ticagrelor and rivaroxaban in trauma patients needing urgent orthopedic surgery.
Protocol for CytoSorb in anticoagulant trauma surgery; leaves open whether hemoadsorption safely mitigates perioperative bleeding.
Background: Major orthopedic trauma in patients receiving anticoagulants such as ticagrelor or rivaroxaban poses a significant perioperative challenge, particularly in emergency contexts where bleeding risks are heightened and specific reversal agents may be unavailable. CytoSorb®, a hemoadsorption device, has demonstrated efficacy in cardiac surgery for drug removal. Its potential application in trauma surgery remains unexplored. Objective: This protocol describes a prospective clinical investigation assessing the feasibility and safety of CytoSorb® hemoadsorption for the preoperative removal of ticagrelor and rivaroxaban in trauma patients requiring urgent orthopedic surgery. Methods: The proposed intervention involves integrating CytoSorb® into a dedicated extracorporeal circuit under normothermic conditions (37 °C) with a blood flow of 150–200 mL/min for 300 min. Serial plasma samples will be collected at predefined intervals (0, 30, 60, 120, 240, 300 min) and drug concentrations. The primary outcome is the pharmacokinetic profile of drug clearance. Secondary endpoints include procedural safety, bleeding complications, and the feasibility of timely surgery. Expected Impact: The study aims to provide real-world data on the practical integration of CytoSorb® for anticoagulant removal in orthopedic trauma care, potentially facilitating earlier surgery and improving perioperative safety. Findings may inform future randomized trials and protocol standardization.
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Melegari et al. (2025) studied Major orthopedic trauma in patients receiving ticagrelor or rivaroxaban. CytoSorb® hemoadsorption was evaluated on Pharmacokinetic profile of drug clearance. This protocol outlines a prospective study to evaluate CytoSorb hemoadsorption for clearing ticagrelor and rivaroxaban before urgent orthopedic surgery; no results are available yet.
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